Chemotherapy for Patients With Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 4

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380718

H3E-MC-JMIC (Other Identifier)

10720

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
• Patients' NSCLC must have progressed following one chemotherapy regimen for palliative therapy with or without subsequent targeted biological therapy
• Disease status must be that of measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion criteria

• Concurrent administration of any other tumor therapy
• Pregnancy or breast feeding
• Serious concomitant disorders
• Inability or unwillingness to take folic acid or vitamin B12 supplementation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Pemetrexed

Experimental group

Treatment:

Drug: pemetrexed